FDA 510(k) Application Details - K221014

Device Classification Name Conserver, Oxygen

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510(K) Number K221014
Device Name Conserver, Oxygen
Applicant Effortless Oxygen. LLC
251 E Sierra Dr.
Phoenix, AZ 85012 US
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Contact Samir Ahmad
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Regulation Number 868.5905

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Classification Product Code NFB
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Date Received 04/05/2022
Decision Date 10/17/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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